DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

Reye's syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

hives

facial swelling

asthma (wheezing)

shock

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

are age 60 or older

have had stomach ulcers or bleeding problems

take a blood thinning (anticoagulant) or steroid drug

take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)

have 3 or more alcoholic drinks every day while using this product

take more or for a longer time than directed

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

stomach bleeding warning applies to you

you have a history of stomach problems, such as heartburn

you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

you are taking a diuretic

you have asthma

Ask a doctor or pharmacist before use if you are taking a prescription drug for

gout

diabetes

arthritis

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical right away.

you experience any of the following signs of stomach bleeding:

feel faint

vomit blood

have bloody or black stools

have stomach pain that does not get better

pain gets worse or lasts more than 10 days

redness or swelling is present

new symptoms occur

ringing in the ears or a loss of hearing occurs

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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